Bellerophon Therapeutics announced positive topline data from the phase 2b study of INOpulse® (pulsed, inhaled nitric oxide) delivery system for the treatment of pulmonary hypertension associated with pulmonary fibrosis (PH-PF).
The INOpulse delivery system is a portable device designed to deliver nitric oxide via a proprietary triple-lumen nasal cannula directly to the well-ventilated parts of the lung matching ventilation to perfusion (V/Q matching) and improving oxygenation. The Company believes INOpulse will allow inhaled nitric oxide, which is inactivated shortly after contact with blood, to be locally administered to blood vessels with minimal systemic effects.
The phase 2b, open-label, PHPF-002 study evaluated the hemodynamic effects of increasing doses of INOpulse in 16 patients with pulmonary hypertension associated with pulmonary fibrosis or sarcoidosis on long term oxygen therapy. Patients received iNO 30, 45, 75, and 125 mcg/kg IBW/hr followed by a long-term extension safety study.
Results demonstrated that patients treated with INOpulse showed statistically and clinically significant improvements, including a 21% reduction in pulmonary vascular resistance with an increased benefit (P <.01) from iNO30 (30mcg/kg IBW/hr) to iNO45 (45mcg/kg IBW/hr) during dose escalation. Additionally, treatment with INOpulse was associated with a 12% reduction in mean pulmonary arterial pressure. INOpulse was found to be well tolerated with no safety concerns across the doses.
“The benefits demonstrated in our multiple phase 2 studies support INOpulse’s potential to become a transformative therapy for PH-PF patients,” said Fabian Tenenbaum, CEO of Bellerophon. “The hemodynamic dose response data generated in PHPF-002 validate the pulmonary vasodilatory capability of INOpulse, confirming the therapeutic benefit of iNO30 and supporting further benefit on iNO45 […] We look forward to further assessing the benefit of INOpulse in our upcoming pivotal phase 3 study.”
For more information visit bellerophon.com.